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Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Endoscopic Ultrasound Findings in Esophageal Atresia Following Surgical Repair

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04259528
Enrollment
50
Registered
2020-02-06
Start date
2020-03-01
Completion date
2021-07-30
Last updated
2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Atresia

Brief summary

Children with esophageal atresia who undergo surgical repair are at risk for anastomotic stricture following surgery. Esophageal stricture can be treated with serial endoscopic dilation but may ultimately need surgical resection if the stricture proves refractory to therapy. Several risk factors have been reported for development of recalcitrant stricture, but to date, no studies have specifically examined the relationship between anastomotic thickness and echotexture at time of initial postoperative endoscopy and treatment outcomes. Other risk factors that have been implicated in the development of recalcitrant stricture include gastroesophageal reflux disease, anastomotic leak, long-gap esophageal atresia, and gestational age. Moreover, it is poorly understood how esophageal layers alter and progress with repeated therapeutic dilation. The investigator hypothesize that the initial thickness and echotexture will help determine therapeutic outcome. It will also help us understand the progression of esophageal echotexture following therapeutic dilation.

Interventions

DEVICEPediatric endoscopic ultrasound

endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 21 Years
Healthy volunteers
No

Inclusion criteria

\- Patients ages 0-21 years old at time of evaluation with a suspected diagnosis of esophageal stricture secondary to esophageal atresia (with or without Tracheoesophageal fistula) post surgical repair

Exclusion criteria

* Patients with pre-diagnosis of eosinophilic esophagitis * Patients with pre-diagnosis of congenital esophageal stricture * Patients diagnosed with esophageal stricture secondary to caustic ingestion * Patient is diagnosed with an esophageal perforation at time of endoscopy

Design outcomes

Primary

MeasureTime frameDescription
Predict post surgical primary repair outcome in patients with esophageal atresia using endoscopic ultrasound2 yearsPatients with esophageal atresia following surgical repair will undergo an endoscopic ultrasound procedure to measure esophageal layer thickness and to describe esophageal echo-texture characteristics at the anastomotic site

Contacts

Primary Contactosama baghdadi, MBBS
osama.baghdadi@childrens.harvard.edu6173556058

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026